drugset / Trial / NCT02156570

DAA-based Therapy for Recently Acquired Hepatitis C II (DAA = Directly Acting Antiviral)

NCT02156570

Phase 4 Completed 20 enrolled Kirby Institute
NaSingle-groupOpen-labelTreatment

Summary

The purpose of the study is to examine whether patients who have acute or early chronic hepatitis C virus (HCV) infection can be treated effectively and safely with an interferon-sparing regimen that combines a new direct acting antiviral drug (sofosbuvir) with one of the standard treatments for chronic hepatitis C (ribavirin). In particular, this study will investigate whether treatment of acute or early chronic HCV can be shortened. The study will assess efficacy by looking at the proportion of people who clear the virus (have no virus detectable in their blood) at the end of treatment, and 1, 3 and 6 months after treatment. The hypothesis is that short course (6 weeks) dual therapy using sofosbuvir and RBV will result in successful virological eradication in the majority (≥80%) of subjects treated for recently acquired HCV.

Timeline

Start
2014-10
Primary completion
2017-08
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Ribavirin Small molecule 1000 mg
Subject Ribavirin Small molecule 1200 mg
Subject Sofosbuvir Small molecule 400 mg